Malignant Neoplasm of BreastPhase 3NCT01953003
Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
A Phase 3 study testing vinflunine and Capecitabine in people with Malignant Neoplasm of Breast, run by Pierre Fabre Medicament at 18 sites in 3 countries.
Trial summary
Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. Capecitabine currently has a role in this setting, yet as many as 80% of patients do not respond to this treatment and those who respond eventually develop clinical resistance. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Malignant Neoplasm of Breast
- What is being tested?
- vinflunine and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Sep 2013to Jul 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Histologically or cytologically confirmed Her-2 negative carcinoma of the breast
- Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy
- One, two or three prior chemotherapy regimens including those administered in the neoadjuvant or adjuvant setting. At least one of the regimens must have been given for the treatment of advanced disease.
- Prior treatment must have included both an anthracycline and a taxane. minimum cumulative dose of 180 mg/m² of doxorubicin or of 300 mg/m² of epirubicin
- Documented progression on or within 12 months of the most recent chemotherapy.
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- Prior hormone therapy is allowed
- Prior radiation therapy is allowed to less than 30% of the bone marrow
- LMeasurable or non measurable disease defined according to RECIST V1.1
- Adequate recovery from recent surgery
- Estimated life expectancy superior or equal of 12 weeks
- KPS equal or superior to 70%
- Age equal or superior to 21 years and < 80 years
- ANC) equal or superior to 1.5 x 109/L, platelet count equal or superior to 100 x109/L and haemoglobin > 10 g/dL.
- Bilirubin inferior or equal to 1.5 x upper limit of normal (ULN), AST and ALT inferior or equal to 2.5 x ULN or inferior or equal to 5 x ULN in the case of liver metastases, alkaline phosphatase inferior or equal to 5 x ULN.
- Calculated creatinine clearance superior or equal to 50 mL/min
- Normal ECG
- Patients on coumadin or warfarin must be on stable doses and INR inferior or equal to 3
- Women of childbearing potential must be using a medically accepted method of contraception. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first treatment administration.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
Who cannot join
- Known or with clinical evidence of brain metastasis or leptomeningeal involvement.
- Pulmonary lymphangitis or symptomatic pleural effusion (grade > 2) that results in pulmonary dysfunction requiring active treatment.
- Patients having received any other experimental drug or chemotherapy within 30 days
- History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years previously with no evidence of recurrence
- Pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade >1
- Patients having received > 3 regimens of chemotherapy
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- Prior therapy with capecitabine and/or vinca-alkaloids
- History of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or any contra indication to any of the study drugs
- Known or suspected DPD
- Pregnant or lactating; With positive pregnancy test at inclusion
- Female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment
- Known history of HIV infection
- Inability to take and/or absorb oral medication
- Any serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia, congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction within 6 months prior to randomisation.
- Prior BMT or autologous stem cell infusion following high-dose chemotherapy.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
China13 sites
Study site
Beijing
Study site
Changchun
Study site
Chengdu
Study site
Dalian
Study site
Fuzhou
Study site
Hangzhou
Study site
Harbin
Study site
Jinan
Study site
Nanjing
Study site
Shanghai
Study site
Shenyang
Study site
Tianjin
Study site
Wuhan
About this study
Official title: A Multicenter, Randomised, Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously
Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. Capecitabine currently has a role in this setting, yet as many as 80% of patients do not respond to this treatment and those who respond eventually develop clinical resistance.
The antitumour activity of vinflunine has been demonstrated in patients with breast cancer after exposure to anthracycline and to taxane.
Read more
Vinflunine plus capecitabine has been shown to be a feasible combination for patients previously treated with an anthracycline and a taxane. Each drug in combination can be administered at efficacious doses.
This population has few therapeutic options with established clinical benefit. The development of a new regimen and potential new standard of care for this group is important.
- Primary objective:
- to compare in patients with advanced breast cancer pretreated with anthracycline and taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine alone, in terms of progression-free survival.
- Secondary objectives:
- to evaluate the response rate, the time to response and the duration of response in both arms
- to compare the disease control rate between arms
- to evaluate the duration of disease control in both arms
- to evaluate the overall survival in both arms
- to evaluate safety
Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of 334 patients with advanced breast cancer who have previously been treated with an anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus capecitabine (Arm A) or capecitabine alone (Arm B).
Read the detailed description
RECIST 1.1 will be used for tumor assessment CTC - CAE version 3.0 will be used for safety assessment
- Conditions
- Malignant Neoplasm of Breast
- Being tested
- vinflunine, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinflunineDrug
Also called Javlor
intravenous administration day 1 once every 3 weeks, 280 mg/m²
CapecitabineDrug
Also called xeloda, from day 1 to day 14
Arm A : 1650 mg/m² Arm B : 2500 mg/m²
| Study group | Role | What they receive |
|---|---|---|
| Arm A : iv vinflunine plus Capecitabine | Experimental | Vinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest. Receives: Drug: vinflunine; Drug: Capecitabine |
| capecitabineArm B : capecitabine | Active comparator | 1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest Receives: Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
The primary endpoint for the trial is progression-free survival calculated from the date of randomisation until the date of progression or the date of death whatever the cause of death. Patient who does not progressed will be censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression.
Measured: progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binghe XU, MD, Study chair, Cancer Institute & Hospital. Chinese Academy of Medical Sciences, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953003
- Sponsor's protocol ID
- L00070 IN 311 B0
- Status last verified
- Jan 2019
- First submitted
- 13 Aug 2013
- Last updated
- 2 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomised, Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously
- ClinicalTrials.gov ID
- NCT01953003
- Acronym / sponsor ID
- L00070 IN 311 B0
- Conditions
- Malignant Neoplasm of Breast
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Sep 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 2 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. Capecitabine currently has a role in this setting, yet as many as 80% of patients do not respond to this treatment and those who respond eventually develop clinical resistance.
The antitumour activity of vinflunine has been demonstrated in patients with breast cancer after exposure to anthracycline and to taxane.
Vinflunine plus capecitabine has been shown to be a feasible combination for patients previously treated with an anthracycline and a taxane. Each drug in combination can be administered at efficacious doses.
This population has few therapeutic options with established clinical benefit. The development of a new regimen and potential new standard of care for this group is important.
- Primary objective:
- to compare in patients with advanced breast cancer pretreated with anthracycline and taxane the efficacy of the combination of vinflunine and capecitabine with capecitabine alone, in terms of progression-free survival.
- Secondary objectives:
- to evaluate the response rate, the time to response and the duration of response in both arms
- to compare the disease control rate between arms
- to evaluate the duration of disease control in both arms
- to evaluate the overall survival in both arms
- to evaluate safety
Methodology This multicentre, open-label, randomised, Phase III study will enrol a total of 334 patients with advanced breast cancer who have previously been treated with an anthracycline and a taxane. Patients will be randomised in a 1:1 ratio to receive VFL plus capecitabine (Arm A) or capecitabine alone (Arm B).
Detailed description
RECIST 1.1 will be used for tumor assessment CTC - CAE version 3.0 will be used for safety assessment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : iv vinflunine plus Capecitabine | Experimental | Drug: vinflunine, Drug: CapecitabineVinflunine dose 280 mg/m² on day 1 of each cycle every 3 weeks, Capecitabine 825 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest. |
| capecitabineArm B : capecitabine | Active comparator | Drug: Capecitabine1250 mg/m² twice daily orally for 14 consecutive days beginning on day 1 of each cycle followed by 1 week of rest |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Written informed consent
- Histologically or cytologically confirmed Her-2 negative carcinoma of the breast
- Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy
- One, two or three prior chemotherapy regimens including those administered in the neoadjuvant or adjuvant setting. At least one of the regimens must have been given for the treatment of advanced disease.
- Prior treatment must have included both an anthracycline and a taxane. minimum cumulative dose of 180 mg/m² of doxorubicin or of 300 mg/m² of epirubicin
Key exclusion criteria (15 listed)
- Known or with clinical evidence of brain metastasis or leptomeningeal involvement.
- Pulmonary lymphangitis or symptomatic pleural effusion (grade > 2) that results in pulmonary dysfunction requiring active treatment.
- Patients having received any other experimental drug or chemotherapy within 30 days
- History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years previously with no evidence of recurrence
- Pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade >1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vinflunineAlso: Javlorintravenous administration day 1 once every 3 weeks, 280 mg/m² | Drug | Arm A : iv vinflunine plus Capecitabine |
| CapecitabineAlso: xeloda, from day 1 to day 14Arm A : 1650 mg/m² Arm B : 2500 mg/m² | Drug | Arm A : iv vinflunine plus Capecitabine, capecitabineArm B : capecitabine |
Primary outcome
Progression Free Survival (PFS)
Time frame: progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years
The primary endpoint for the trial is progression-free survival calculated from the date of randomisation until the date of progression or the date of death whatever the cause of death. Patient who does not progressed will be censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binghe XU, MD study chair
Cancer Institute & Hospital. Chinese Academy of Medical Sciences, Beijing
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vinflunine and Capecitabine in people with Malignant Neoplasm of Breast, run by Pierre Fabre Medicament at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China, Taiwan, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.